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Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (guardian™ 5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035384
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date January 10, 2014
First Posted Date January 14, 2014
Last Update Posted Date April 27, 2020
Actual Study Start Date June 5, 2014
Actual Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 3, 2017)
Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors [ Time Frame: Within approximately 7 years ]
Original Primary Outcome Measures
 (submitted: January 10, 2014)
Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU)/mL for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors [ Time Frame: Within approximately 4 years ]
Change History
Current Secondary Outcome Measures
 (submitted: November 3, 2017)
  • Number of adverse reactions reported [ Time Frame: During approximately 7 years ]
  • Number of serious adverse reactions reported [ Time Frame: During approximately 7 years ]
  • Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None [ Time Frame: Within approximately 7 years ]
  • Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None [ Time Frame: Within approximately 7 years ]
  • Annualised bleeding rate for patients using turoctocog alfa for preventive treatment [ Time Frame: Within approximately 7 years ]
  • Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment [ Time Frame: Within approximately 7 years ]
Original Secondary Outcome Measures
 (submitted: January 10, 2014)
  • Number of adverse reactions reported [ Time Frame: During approximately 4 years ]
  • Number of serious adverse reactions reported [ Time Frame: During approximately 4 years ]
  • Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None [ Time Frame: Within approximately 4 years ]
  • Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None [ Time Frame: Within approximately 4 years ]
  • Annualised bleeding rate for patients using turoctocog alfa for preventive treatment [ Time Frame: Within approximately 4 years ]
  • Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment [ Time Frame: Within approximately 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A
Official Title A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)
Brief Summary This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Previously FVIII treated (more than 150 exposure days) patients with severe and moderately severe haemophilia A with FVIII below or equal to 2%.
Condition
  • Congenital Bleeding Disorder
  • Haemophilia A
Intervention Drug: turoctocog alfa
Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.
Study Groups/Cohorts All patients
Intervention: Drug: turoctocog alfa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 24, 2020)
69
Original Estimated Enrollment
 (submitted: January 10, 2014)
70
Actual Study Completion Date January 15, 2020
Actual Primary Completion Date January 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
  • Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%)
  • The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study
  • A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa

Exclusion Criteria:

  • Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information)
  • Treatment with any investigational drug within 30 days prior to enrolment into the study
  • Previous participation in any clinical trial with turoctocog alfa
  • Treatment with other FVIII products after initiation of treatment with turoctocog alfa
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Czechia,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Poland,   Slovakia,   Slovenia,   Spain,   Sweden,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02035384
Other Study ID Numbers NN7008-3553
U1111-1126-0353 ( Other Identifier: WHO )
ENCEPP/SDPP/5501 ( Registry Identifier: EU PAS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date April 2020